Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635629
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Prospective Evaluation of Desmopressin Stimulation Test Performance in ACTH-dependent Cushing s Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Cushing syndrome CS is a set of diseases that develop when the body produces too much adrenocorticotropic hormone ACTH ACTH stimulates the production of a hormone called cortisol Excess cortisol can cause serious issues such as diabetes high blood pressure weight gain and mood changes Diagnosing CS early can be difficult One test used to diagnose CS the desmopressin Desmo stimulation test DesmoST has not been studied in enough people to know how accurate it is
Objective
To find ways to improve the DesmoST Researchers especially want to learn more about how well the DesmoST identifies people with specific ACTH CSs Cushing disease CD and ectopic ACTH syndrome EAS
Eligibility
People aged 18 to 70 years who have or may have CS especially CD or EAS Healthy volunteers are also needed
Design
Participants with CS will have 3 DesmoSTs at least 48 hours apart The procedure for each is as follows
They will limit their fluid intake the day before each test They will have nothing to eat or drink for 12 hours before the test
For 1 of the tests they will take a pill that contains a hormone dexamethasone They will take it around 11 pm the day before the test
Desmo is given through a tube attached to a needle inserted into a vein
Blood will be drawn a total of 6 times before and after the desmo is given
Healthy volunteers will have 4 DesmoSTs These will be 2 to 14 days apart
All participants will have follow-up visits 3 to 5 days after each test These visits may be by phone
Cushing syndrome CS is a set of diseases that develop when the body produces too much adrenocorticotropic hormone ACTH ACTH stimulates the production of a hormone called cortisol Excess cortisol can cause serious issues such as diabetes high blood pressure weight gain and mood changes Diagnosing CS early can be difficult One test used to diagnose CS the desmopressin Desmo stimulation test DesmoST has not been studied in enough people to know how accurate it is
Objective
To find ways to improve the DesmoST Researchers especially want to learn more about how well the DesmoST identifies people with specific ACTH CSs Cushing disease CD and ectopic ACTH syndrome EAS
Eligibility
People aged 18 to 70 years who have or may have CS especially CD or EAS Healthy volunteers are also needed
Design
Participants with CS will have 3 DesmoSTs at least 48 hours apart The procedure for each is as follows
They will limit their fluid intake the day before each test They will have nothing to eat or drink for 12 hours before the test
For 1 of the tests they will take a pill that contains a hormone dexamethasone They will take it around 11 pm the day before the test
Desmo is given through a tube attached to a needle inserted into a vein
Blood will be drawn a total of 6 times before and after the desmo is given
Healthy volunteers will have 4 DesmoSTs These will be 2 to 14 days apart
All participants will have follow-up visits 3 to 5 days after each test These visits may be by phone
Detailed Description:
Study Description
The goal of this study is to improve the diagnostic accuracy of the Desmopressin stimulation test DesmoST for three indications to identify the etiology of ACTH-dependent Cushing syndrome CS as either Cushing Disease CD or Ectopic ACTH Syndrome EAS to discriminate between non-CS subjects healthy controls and patients with pseudo-CS and CD and to identify CD in patients with cyclic hypercortisolism or recurrence Test conditions include ad libitum water intake vs fluid restriction increased glucocorticoid negative feedback 1 mg dexamethasone and variable doses of desmopressin 4 mcg vs 10 mcg We hypothesize that fluid restriction via increased endogenous vasopressin levels increased glucocorticoid negative feedback and a lower dose of desmopressin improve specificity
Objectives
-Primary Objective
To evaluate the hormonal response to desmopressin in subjects with ACTHdependent Cushing syndrome CD and EAS and non-CS subjects healthy controls pseudo-CS under different conditions
-Secondary Objective
To evaluate the DesmoST performance sensitivity specificity diagnostic accuracy in identifying CD and distinguishing it from EAS and non-CS under different conditions
-Exploratory Objectives
To evaluate the ability of the DesmoST to identify CD in patients with cyclic hypercortisolism or postoperative recurrence to evaluate whether Factor VIII is a biomarker for desmopressin action and to explore the relationship between fluid status and response to desmopressin
Endpoints
-Primary Endpoints
Percentage change of peak ACTH and cortisol from baseline levels during the DesmoST under different conditions
-Secondary Endpoints
Cut-off points of relative ACTH and cortisol increase during the DesmoST that produce optimal diagnostic accuracy once diagnostic information from other testsimaging has been used to categorize subjects with suspected CS as having CD EAS or pseudo-CS
-Exploratory Endpoints
Percent change of peak ACTH and cortisol from baseline during the DesmoST in patients categorized as having cyclic hypercortisolism postoperative recurrence and fluid replete or restricted the change in factor VIII levels after desmopressin administration
The goal of this study is to improve the diagnostic accuracy of the Desmopressin stimulation test DesmoST for three indications to identify the etiology of ACTH-dependent Cushing syndrome CS as either Cushing Disease CD or Ectopic ACTH Syndrome EAS to discriminate between non-CS subjects healthy controls and patients with pseudo-CS and CD and to identify CD in patients with cyclic hypercortisolism or recurrence Test conditions include ad libitum water intake vs fluid restriction increased glucocorticoid negative feedback 1 mg dexamethasone and variable doses of desmopressin 4 mcg vs 10 mcg We hypothesize that fluid restriction via increased endogenous vasopressin levels increased glucocorticoid negative feedback and a lower dose of desmopressin improve specificity
Objectives
-Primary Objective
To evaluate the hormonal response to desmopressin in subjects with ACTHdependent Cushing syndrome CD and EAS and non-CS subjects healthy controls pseudo-CS under different conditions
-Secondary Objective
To evaluate the DesmoST performance sensitivity specificity diagnostic accuracy in identifying CD and distinguishing it from EAS and non-CS under different conditions
-Exploratory Objectives
To evaluate the ability of the DesmoST to identify CD in patients with cyclic hypercortisolism or postoperative recurrence to evaluate whether Factor VIII is a biomarker for desmopressin action and to explore the relationship between fluid status and response to desmopressin
Endpoints
-Primary Endpoints
Percentage change of peak ACTH and cortisol from baseline levels during the DesmoST under different conditions
-Secondary Endpoints
Cut-off points of relative ACTH and cortisol increase during the DesmoST that produce optimal diagnostic accuracy once diagnostic information from other testsimaging has been used to categorize subjects with suspected CS as having CD EAS or pseudo-CS
-Exploratory Endpoints
Percent change of peak ACTH and cortisol from baseline during the DesmoST in patients categorized as having cyclic hypercortisolism postoperative recurrence and fluid replete or restricted the change in factor VIII levels after desmopressin administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None